(89 days)
Not Found
No
The summary describes a mechanical spinal implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as treating various medical conditions of the lumbosacral spine, such as fractures, tumors, degenerative disease, and spondylolisthesis, which are conditions that require therapeutic intervention.
No
The device is a lumbar plate system used to stabilize unstable spines, not diagnose conditions. It is a surgical implant for treatment, not diagnosis.
No
The device description explicitly states it consists of physical components like plates and screws made from titanium alloy, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided text clearly describes a surgical implant system (plates and screws) used to stabilize the spine during surgery. It is physically implanted into the patient's body.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information about a patient's health status. Its purpose is mechanical stabilization.
Therefore, based on the provided information, the VICTORY™ Lumbar Plate System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VICTORY™ Lumbar Plate System is indicated for use through an anterior, lateral or anterolateral surgical approach above the bifurcation of the great vessels, or through an anterior surgical approach below the great vessels in the treatment of lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolisthesis, scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery.
The VICTORY™ Buttress Plate is intended to stabilize allograft at one level (L1-S1), aiding in spinal fusion and to provide temporary stabilization and augment of a spinal fusion. The device is not intended for load bearing applications.
Product codes
KWQ
Device Description
The VICTORY™ Lumbar Plate System consists of 3- and 4-screw plates, buttress plates, and bone screws in various sizes to accommodate varying patient anatomy and surgical needs. The plates attach to the anterior, anterolateral portion of the lumbar or lumbosacral spine. The plates are used with variable angle screws. The implants are manufactured from titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbosacral (L1-S1) spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Mechanical testing (static and dynamic compression bending and static torsion) was conducted in accordance with ASTM F1717, the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004, and the "Guidance for Industry and FDA Staff: Spinal Plating Systems - Performance Criteria for Safety and Performance Based Pathway," December 11, 2020. Expulsion testing of the buttress plates was also conducted. Performance data demonstrate substantial equivalence to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K062836, K050117, K052546, K221050, K142699
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
October 31, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Globus Medical, Inc Jennifer Antonacci Group Manager, Regulatory Affairs Valley Forge Business Center 2560 General Armistead Ave Audubon, Pennsylvania 19403
Re: K232318
Trade/Device Name: VICTORY™ Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 2, 2023 Received: August 3, 2023
Dear Jennifer Antonacci:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Colin o'neill -SFD
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K232318
Device Name VICTORY™ Lumbar Plate System
Indications for Use (Describe)
The VICTORY™ Lumbar Plate System is indicated for use through an anterior, lateral or anterolateral surgical approach above the bifurcation of the great vessels, or through an anterior surgical approach below the great vessels in the treatment of lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolisthesis, scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery.
The VICTORY™ Buttress Plate is intended to stabilize allograft at one level (L1-S1), aiding in spinal fusion and to provide temporary stabilization and augment of a spinal fusion. The device is not intended for load bearing applications.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary: VICTORY™ Lumbar Plate System
| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
610-930-1800 | |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact: | Jennifer Antonacci, Ph.D.
Group Manager, Regulatory Affairs | |
| Date Prepared: | October 30, 2023 | |
| Device Name: | VICTORY™ Lumbar Plate System | |
| Common Name: | Lumbar Plate System | |
| Classification: | Per 21 CFR as follows:
§888.3060 Spinal Intervertebral Body Fixation Orthosis
Product Code: KWQ
Regulatory Class II, Panel Code 87 | |
| Primary
Predicate: | CITADEL™ Anterior Lumbar Plate System (K062836) | |
| Additional
Predicates: | Medtronic PYRAMID®
Anterior Plate Fixation
System
(K050117)
Depuy AEGIS® Anterior Lumbar Plate System (K052546)
AEGIS® Spinema Lumbar Plate System (K221050)
Stryker LITe® Plate System (K142699) | |
Purpose:
The purpose of this submission is to request clearance for the VICTORY™ Lumbar Plate System.
Device Description:
The VICTORY™ Lumbar Plate System consists of 3- and 4-screw plates, buttress plates, and bone screws in various sizes to accommodate varying patient anatomy and surgical needs. The plates attach to the anterior, anterolateral portion of the lumbar or lumbosacral spine. The plates are used with variable angle screws. The implants are manufactured from titanium alloy.
Indications for Use:
The VICTORY™ Lumbar Plate System is indicated for use through an anterior, lateral or anterolateral surgical approach above the bifurcation of the great vessels, or through an anterior surgical approach below the bifurcation of the great vessels
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in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, deqenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery.
The VICTORY™ Buttress Plate is intended to stabilize allograft or autograft at one level (L1-S1), aiding in spinal fusion and to provide temporary stabilization and augment development of a spinal fusion. The device is not intended for load bearing applications.
Performance Data:
Mechanical testing (static and dynamic compression bending and static torsion) was conducted in accordance with ASTM F1717, the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004, and the "Guidance for Industry and FDA Staff: Spinal Plating Systems - Performance Criteria for Safety and Performance Based Pathway," December 11, 2020. Expulsion testing of the buttress plates was also conducted. Performance data demonstrate substantial equivalence to the predicate devices.
Technoloqical Characteristics:
The VICTORY™ implants have similar technological characteristics as the predicate devices including overall design, intended use, material composition, function, and range of sizes.
Basis of Substantial Equivalence:
The VICTORY™ Lumbar Plate System has been found to be substantially equivalent to the predicate devices with respect to technological characteristics, performance, design and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate devices.